endometrial cancer endometrial cancer
Conditions
Interventions
Arm A:
Standard surgical procedure for endometrial cancer:
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy
(type 2 cancers)
Arm B:
In addition to standard procedures as defined for Ar
Sponsors
Yabuno Akira
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous differentiation,mucinous) or type 2 tumors (any percentage of serous or clear cell component) orcarcinosarcoma 2. a) no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8 weeks after hysterectomy if no LNE was performed (secondary surgery) 3. absence of bulky lymph nodes 4. performance status ECOG 0-1 5. age 18-75 years 6. written informed consent 7. adequate compliance
Exclusion criteria
Exclusion criteria: 1. stage pT1a, G1 or G2 tumors of type1 histology 2. sarcomas (except for carcinosarcoma = malignant mixed Mullerian tumor) 3. EC of FIGO stages IIIor IV (except for microscopical lymph node metastases) 4. evidence of extrauterine disease by visual inspection 5. recurrent EC 6. preceding chemo-, radio, or endocrine therapy for EC 7. any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy 8. any medical history indicating excessive peri-operative risk 9 .any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating 10. any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected. 11. patients with second malignancies if disease or treatment might have an impact on the patient's prognosis 12. known HIV-infection or AIDS 13. simultaneous participation in other clinical trials if not permitted by the steering committee (translational or QoL studies not interfering with the objectives of ECLAT are allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Disease free survival (DFS) -Disease specific survival (DSS) -Assessment of perioperative complications and site effects of LNE -Health related Quality of life (QoL)(EORTC QLQ-C30, EORTC QLQ-EN24) -Number of resected lymph nodes | — |
Countries
Germany, Japan, Korea
Contacts
Public ContactMitsuko Mouri
Kanagawa University of Human Services, Center for Innovation Policy
Outcome results
None listed